User or patient monitoring methods using one or more analysis tools

ABSTRACT

A method is provided for using telemetry data based on user habit information or user monitoring. One or more sensors of a monitoring device detects or measures user information selected from of at least one of, a user&#39;s activities, behaviors and habit information, and a user&#39;s health. The user information is received at a telemetry system with a database. One or more analysis tools at the telemetry system are used for the analysis. Analysis information is produced that is sent to the monitoring device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. Ser. Nos. 13/923,909,13/923,637, 13/923,614, 13/923,809, 13/923,750, 13/923,583, 13/923,560,13/923,543, and U.S. Ser. No. 13/923,937, all filed Jun. 21, 2013 andall of which claim the benefit of U.S. 61/772,265, 61/812,083 and61/823,502. All of the above-identified applications are fullyincorporated herein by reference.

BACKGROUND

1. Field of the Invention

The present invention is directed to methods for monitoring user orpatient parameters, and more particularly to methods that use a useractivity manager, feedback control in combination with a monitoringdevice with a unique user ID and a telemetry system to provide formonitoring a user's activities using one or more analysis tools andprovide feedback.

2. Description of the Related Art

Patient monitoring was accomplished by electronic equipment maintainedat the user's bedside. Vital signs derived from physiological waveformswere monitored with the bedside equipment and alarms were generated ifpredetermined limits were exceeded by the vital signs. This bedsidemonitoring equipment became larger, more complex and expensive as eachbedside unit undertook to monitor more physiological data and providemore sophisticated displays, e.g. color, more and better communicationsand more in-depth analysis of the data, such as calculation of vitalsigns and trends which required memory and processing capability. Theprovision of such units at each appropriate user bedside introducesconsiderable additional expense to the hospital user care costs.

With the introduction of bedside monitoring units, attempts were made toprovide a measure of remote monitoring by transmitting analog waveformsof physiological data from the bedside unit to equipment at a centralstation such as a nurse's station. Subsequently remote monitoringefforts included analog waveforms plus digital representations fordisplay. Both the bedside and remote monitoring activity acted to givealarms upon sensing an abnormal condition and to store data and analyzedata to obtain vital signs and trends. But these systems are basicallyone-way systems reporting physiological data from the user. There is nocommunication with the user as a part of an interactive integratedsystem.

Telemetry systems can be implemented to acquire and transmit data from aremote source. Some telemetry systems provide information about a user'sactivities.

It is becoming commonplace to use wireless packet data service networksfor effectuating data sessions with. In some implementations, uniqueidentifications (ID) need to be assigned to the devices in order tofacilitate certain aspects of service provisioning, e.g., security,validation and authentication, et cetera. In such scenarios, it becomesimperative that no two devices have the same indicium (i.e., collision).Further, provisioning of such indicia should be flexible so as tomaintain the entire pool of indicia to a manageable level while allowingfor their widespread use in multiple service environments.

Medical telemetry systems may comprise an alarm adapted to identify highrisk users and/or users requiring special assistance. Some medicalprocedures and diagnostic examinations require the removal of anytelemetry system components attached directly to a user. One problemwith conventional medical telemetry systems is that the process ofremoving telemetry system components for purposes of performing amedical procedure or diagnostic examination can generate a false alarm.False alarms unnecessarily tax hospital resources and interfere with theworking environment.

There is a need for methods using telemetry devices configured to beused for user lifestyle management, monitoring user behavior, useractivity and habits and health monitoring. There is a further need forwireless communication methods with monitoring devices that have sensorsused for a monitoring user behavior, user activity and habits and healthmonitoring, analysis of the monitoring followed by feedback alerts.

SUMMARY OF THE INVENTION

An object of the present invention is to provide methods that providetools for analysis and feedback for medical and lifestyle management.

Another object of the present invention is to provide methods formedical and lifestyle management using user habit information or usermonitoring, analysis tools and feedback.

A further object of the present invention is to provide methods formedical and lifestyle management using monitoring devices with sensorsthat monitor one or more of a user's activities, behaviors and habitinformation, the use of analysis tools followed by providing userfeedback.

Still another object of the present invention is to provide methods formedical and lifestyle management using one or more contexts selectedfrom at least one of, time, location, type of user activity, duration ofuser activity and a status of the user activity, analysis tools used toprovide user feedback.

Yet another object of the present invention is to provide methods thatuse an activity manager and feedback to manage and monitor userlifestyle or medical conditions in response to receiving information fora monitoring device with sensors that monitor one or more of a user'sactivities, behaviors and habit information, following by using analysistools in response to the monitoring.

These and other objects of the present invention are achieved in amethod for using telemetry data based on user habit information or usermonitoring. One or more sensors of a monitoring device detects ormeasures user information selected from of at least one of, a user'sactivities, behaviors and habit information, and a user's health. Theuser information is received at a telemetry system with a database. Oneor more analysis tools at the telemetry system are used for theanalysis. Analysis information is produced that is sent to themonitoring device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1( a) and 1(b) illustrate one embodiment of a wearable device ofthe present invention, where one size fits all.

FIG. 2 illustrates one embodiment of electronics that can be included inthe wearable device.

FIG. 3 illustrates one embodiment of a telemetry system of the presentinvention.

FIG. 4 is a diagram of the programming input schematic of the securesensor/transmitter array of FIG. 7.

FIG. 5 is a block diagram of the system of programming thesensor/transmitter(s) comprising the secure sensor/transmitter array ofFIG. 7.

FIG. 6 is a block diagram of the jam command and security/randomizationbits of the secure sensor/transmitter array of FIG. 7.

FIG. 7 is a logic circuit diagram of the sensor/transmitter programminginput schematic in one embodiment of the present invention.

FIG. 8 is a block diagram of an embodiment of a computer implementedsystem for determining the location of a remote sensor utilizing themethods of the present invention.

FIG. 9 is a block diagram illustrating one embodiment of a SNAPSHOT GPSreceiver for use according to the present invention.

FIG. 10 is a block diagram of a remote sensor shown in communicationwith two different external communication devices.

FIG. 11 is a diagram of the active RF and RF backscatter antennas.

FIG. 12 is a diagram of the encoding scheme for the symbols in theactive RF protocol.

FIG. 13 is a diagram of the packet structure in the IRDA protocol.

FIG. 14 is a diagram of the encoding scheme in the IRDA protocol.

FIG. 15 illustrates one embodiment of an activity manager that isincluded in the monitoring device, the telemetry system or as astandalone device.

FIG. 16 illustrates one embodiment of an activity manager in oneembodiment of the present invention.

FIG. 17( a) and (b) illustrate an exemplary user interface for anactivity management application according to an embodiment of thepresent invention.

FIG. 18 is a timing diagram illustrating one example of monitoring anactivity based on one or more contexts according to an embodiment of thepresent invention;

FIG. 19 is a block diagram illustrating one embodiment of a monitoringdevice of the present invention.

FIG. 20 illustrates an embodiment of the present invention that includesa feedback system or subsystem.

FIG. 21 is a flow chart illustrating one embodiment of proving feedbackand/or alerts to a user or patient.

FIG. 22 is a flow chart illustrating one embodiment for a method ofestablishing control parameters for a monitoring device user or patientfeedback or alert signal and a sensor signal threshold range for thefeedback or alert signal.

DETAILED DESCRIPTION

As used herein, the term engine refers to software, firmware, hardware,or other component that can be used to effectuate a purpose. The enginewill typically include software instructions that are stored innon-volatile memory (also referred to as secondary memory). When thesoftware instructions are executed, at least a subset of the softwareinstructions can be loaded into memory (also referred to as primarymemory) by a processor. The processor then executes the softwareinstructions in memory. The processor may be a shared processor, adedicated processor, or a combination of shared or dedicated processors.A typical program will include calls to hardware components (such as I/Odevices), which typically requires the execution of drivers. The driversmay or may not be considered part of the engine, but the distinction isnot critical.

As used herein, the term database is used broadly to include any knownor convenient means for storing data, whether centralized ordistributed, relational or otherwise.

As used herein a mobile device includes, but is not limited to, a cellphone, such as Apple's iPhone®, other portable electronic devices, suchas Apple's iPod Touches®, Apple's iPads®, and mobile devices based onGoogle's Android® operating system, and any other portable electronicdevice that includes software, firmware, hardware, or a combinationthereof that is capable of at least receiving the signal, decoding ifneeded, exchanging information with a transaction server to verify thebuyer and/or seller's account information, conducting the transaction,and generating a receipt. Typical components of mobile device mayinclude but are not limited to persistent memories like flash ROM,random access memory like SRAM, a camera, a battery, LCD driver, adisplay, a cellular antenna, a speaker, a BLUETOOTH® circuit, and WIFIcircuitry, where the persistent memory may contain programs,applications, and/or an operating system for the mobile device.

As used herein, the terms “social network” and “SNET” comprise agrouping or social structure of devices and/or individuals, as well asconnections, links and interdependencies between such devices and/orindividuals. Members or actors (including devices) within or affiliatedwith a SNET may be referred to herein as “nodes”, “social devices”,“SNET members”, “SNET devices”, “user devices” and/or “modules”. Inaddition, the terms “SNET circle”, “SNET group” and “SNET sub-circle”generally denote a social network that comprises social devices and, ascontextually appropriate, human SNET members and personal area networks(“PANs”).

A used herein, the term “wearable device” is anything that can be wornby an individual and that has a back side that in some embodimentscontacts a user's skin and a face side. Examples of wearable deviceinclude but are not limited to a cap, arm band, wristband, garment, andthe like.

As used herein, the term “computer” is a general purpose device that canbe programmed to carry out a finite set of arithmetic or logicaloperations. Since a sequence of operations can be readily changed, thecomputer can solve more than one kind of problem. A computer can includeof at least one processing element, typically a central processing unit(CPU) and some form of memory. The processing element carries outarithmetic and logic operations, and a sequencing and control unit thatcan change the order of operations based on stored information.Peripheral devices allow information to be retrieved from an externalsource, and the result of operations saved and retrieved.

As used herein, the term “Internet” is a global system of interconnectedcomputer networks that use the standard Internet protocol suite (TCP/IP)to serve billions of users worldwide. It is a network of networks thatconsists of millions of private, public, academic, business, andgovernment networks, of local to global scope, that are linked by abroad array of electronic, wireless and optical networking technologies.The Internet carries an extensive range of information resources andservices, such as the inter-linked hypertext documents of the World WideWeb (WWW) and the infrastructure to support email. The communicationsinfrastructure of the Internet consists of its hardware components and asystem of software layers that control various aspects of thearchitecture.

As used herein, the term “extranet” is a computer network that allowscontrolled access from the outside. An extranet can be an extension ofan organization's intranet that is extended to users outside theorganization that can be partners, vendors, and suppliers, in isolationfrom all other Internet users. An extranet can be an intranet mappedonto the public Internet or some other transmission system notaccessible to the general public, but managed by more than one company'sadministrator(s). Examples of extranet-style networks include but arenot limited to:

-   -   LANs or WANs belonging to multiple organizations and        interconnected and accessed using remote dial-up    -   LANs or WANs belonging to multiple organizations and        interconnected and accessed using dedicated lines    -   Virtual private network (VPN) that is comprised of LANs or WANs        belonging to multiple organizations, and that extends usage to        remote users using special “tunneling” software that creates a        secure, usually encrypted network connection over public lines,        sometimes via an ISP.

As used herein, the term “Intranet” is a network that is owned by asingle organization that controls its security policies and networkmanagement. Examples of intranets include but are not limited to:

-   -   A LAN    -   A Wide-area network (WAN) that is comprised of a LAN that        extends usage to remote employees with dial-up access    -   A WAN that is comprised of interconnected LANs using dedicated        communication lines    -   A Virtual private network (VPN) that is comprised of a LAN or        WAN that extends usage to remote employees or networks using        special “tunneling” software that creates a secure, usually        encrypted connection over public lines, sometimes via an        Internet Service Provider (ISP).

For purposes of the present invention, the Internet, extranets andintranets collectively are referred to as (“Network Systems”).

As used herein, the term “user” includes but is not limited to a person,under a physician's care, interested in maintaining health, interestedin maintaining a healthy lifestyle and/or physiologic balance,interested in monitoring lifestyle conditions, including but not limitedto, the way a person goes about daily living including but not limitedto, habits, exercise, diet, medical conditions and treatments, career,financial means, emotional status, and the like.

As used herein, the term “user monitoring” includes: (i) Cardiacmonitoring, which generally refers to continuous electrocardiographywith assessment of the user's condition relative to their cardiacrhythm. A small monitor worn by an ambulatory user for this purpose isknown as a Holter monitor. Cardiac monitoring can also involve cardiacoutput monitoring via an invasive Swan-Ganz catheter (ii) Hemodynamicmonitoring, which monitors the blood pressure and blood flow within thecirculatory system. Blood pressure can be measured either invasivelythrough an inserted blood pressure transducer assembly, or noninvasivelywith an inflatable blood pressure cuff. (iii) Respiratory monitoring,such as: pulse oximetry which involves measurement of the saturatedpercentage of oxygen in the blood, referred to as SpO2, and measured byan infrared finger cuff, capnography, which involves CO2 measurements,referred to as EtCO2 or end-tidal carbon dioxide concentration. Therespiratory rate monitored as such is called AWRR or airway respiratoryrate). (iv) Respiratory rate monitoring through a thoracic transducerbelt, an ECG channel or via capnography, (v) Neurological monitoring,such as of intracranial pressure. Special user monitors can incorporatethe monitoring of brain waves electroencephalography, gas anestheticconcentrations, bispectral index (BIS), and the like, (vi) Blood glucosemonitoring using glucose sensors. (vii) Childbirth monitoring withsensors that monitor various aspects of childbirth. (viii) Bodytemperature monitoring which in one embodiment is through an adhesivepad containing a thermoelectric transducer. (ix) Stress monitoring thatcan utilize sensors to provide warnings when stress levels signs arerising before a human can notice it and provide alerts and suggestions.(x) Epilepsy monitoring. (xi) Toxicity monitoring, (xii) generallifestyle parameters and the like.

Additionally the present invention can be used to detect differences fora variety of blood tests, including but not limited to tests for thefollowing: sodium, potassium, chloride, urea, creatinine, calcium,albumin, fasting glucose, amylase, carcinoembryonic antigen,glycosylated hemoglobin, hemoglobin, erthrocytes hemoglobin and thelike.

In various embodiments, the present invention provides a user monitoringdevice 10, including but not limited to, a wearable device, where onesize fits all, Telemetry device 10 can be a sensor enabled item 10,including but not limited to a wearable device, gym bag, wallet, file,shoes, skis, and the like that has its own unique ID. As illustrated inFIGS. 1( a) and 1(b), in one embodiment of the present invention, theuser monitoring device 10 include a plurality of magnets 12, withadjacent magnets having opposite polarity, with a length suitable to beworn by all people. In one embodiment, the length of the user monitoringdevice 10 can be 10-12 inches. The magnets 12 are positioned along aninterior of the user monitoring device 10 to be provided for goodconformation to a user's wrist.

One or more sensors 14 are coupled to the user monitoring device 10. Thesensors are measuring devices. As a non-limiting example, the measuringdevice or sensors 14 can include RTSS devices to detect a user'sactivities, motions, physical parameters, and the like, including butnot limited to, a heart rate monitor, a body temperature probe, aconventional pedometer, an accelerometer and the like.

Alternatively, multifunctional sensors 14 which can perform all theaforementioned functions of RTSS may be attached or embedded in usermonitoring device 10. In one embodiment, each sensor can be incommunication and or connect electronically and/or RF to a telemetrymodule 16. A variety of different sensors 14 can be utilized, includingbut not limited to, an accelerometer based sensor, and pressure basedsensors, voltage resistance sensor, a radio frequency sensor, and thelike, as recited above.

As a non-limiting example, an accelerometer, well known to those skilledin the art, detects acceleration and thus user activity. Theaccelerometer provides a voltage output that is proportional to thedetected acceleration. Accordingly, the accelerometer senses vibration.This voltage output provides an acceleration spectrum over time; andinformation about loft time can be ascertained by performingcalculations on that spectrum. A microprocessor subsystem, such asdisclosed in U.S. Pat. No. 8,352,211, incorporated herein by reference,stores the spectrum into memory and processes the spectrum informationto determine activity. Other examples of suitable accelerometer sensorsare disclosed in EP 2428774 A1, incorporated herein by reference.Suitable pressure sensors are disclosed in EP 1883798 B1, incorporatedherein by reference. A suitable voltage resistance sensor is disclosedin EP 1883798 B1, incorporated herein by reference. A suitable radiofrequency sensor is disclosed in EP 2052352 B1, incorporated herein byreference.

Referring to FIG. 2, in various embodiments, the user monitoring device10, also known as the user monitoring device, can include a power source24, such a battery that can be rechargeable. The battery 24 can be putinto a sleep state when not actively used in order to preserve power. Awake up feature allows the battery 24 and other electronics of the usermonitoring device 10 to “sleep” during non-use or and is initiated intothe “wake up” mode by certain predestinated events.

In one embodiment, as illustrated in FIG. 3, a telemetry system server16 is coupled to a database 18. Each user monitoring device 10 isassigned its own unique identification, ID.

The data transmitted by the user monitoring device 10 sensors 14 and itsID may be coded by appending a seed to digital data bits. As illustratedin FIG. 3 central processor unit 20 (CPU) validates or rejects receivedupon detection of the seed string appended to the digital data bits. Inthe alternative, the digital data bits may be coded and decoded byapplying a scrambling algorithm utilizing the seed. A programming device22 may be configured to transmit data to a sensor 14, also known as auser monitoring device, utilizing a variety of alternative transmissionmeans, including, for example, RF, IR, optical, and the like, or amagnetic loop/induction system.

In one embodiment, sensors 14 are configured to be shipped to users in anon-programmable mode with all programming already performed at thefactory. A random seed may be communicated to the programming device 22can a variety of different mechanisms, including but not limited to, viascanning a bar code, manual input, magnetic strip, random numbergeneration, and the like.

Referring again to FIG. 2, in one embodiment, the user monitoring device10 includes a control unit 26 that puts the user monitoring device 10 ina low power state. A monitoring system 28 can be included that remainsactive. The monitoring system 28 wakes up the electronics 30 in the usermonitoring device 10 from a low power state. The control unit 26 can benotified of awaking of the other components by the monitoring system 28.The control unit 26 can set a status bit on the monitoring system 28only when the battery 24 needs to be in a full power state. The controlunit 26 then forces a power cycle.

Referring to FIG. 3, one embodiment of a telemetry system 32 isillustrated. The telemetry system 32 is in the communication with thesensors 14 and or user monitoring device 14 and ID of the usermonitoring device 10 and can include one or more receivers 34, a centralserver 36 with the CPU 20. The telemetry system 32 can optionallyinclude a display 42 and an alarm 44. The telemetry system 32 receivesinformation from sensors 14 and or the monitoring device of a user'shabits, activities, and the like, and then processes this information.Monitoring device 10 with its unique ID and sensors 14 is assigned to aspecific user in order to track and/or monitor that user. Forillustrative purposes assume that three users A, B AND C are beingtracked and monitored by the telemetry system 32. It should, however, beappreciated that the telemetry system 32 may be implemented to trackand/or monitor a much larger number of users.

In one embodiment of the present invention, radio frequency (RF) devicesthat are sensors 14 and/or chips may serve as the identifying devices.Each source, sensor 14, ID and the like can carry a fixed radiofrequency chip encoded with identifying data which may be correlated tothe individual participants, parts or objects.

Telemetry system 32 of the present invention may include a Real-TimeLocation System (RTLS) 46 and Real-Time Sensing System (RTSS) 48 with RFtechnology. The RF technology may include active and/or passive RFIDsensors 14 and an RF wireless array system as a receiver 34. The RFtechnology in the RTLS 46 and RTSS 48 may include UWB technology (e.g.,IEEE 802.15), WLAN technology (e.g., IEEE 802.11), SAW RFID positioningsystem technology, GPS technology, and the like.

The sensors 14 may communicate directly with each other and/or relaytelemetry data directly to base receiving RF device(s) or base receivers34. The base receivers 34 may forward the telemetry data to a basecomputer either through a direct link or through a Network System.Alternatively the telemetry data may be forwarded to end user devices,including but not limited to, laptops, mobile devices and the like,either directly or through a Network System. The comprehensive telemetrysystem 32 using RF technologies such as UWB, ZigBee, Wi-Fi, GPS datasystem can be utilized as described above.

The readers/antennae may be interconnected using a LAN, such as Ethernetto provide a Network System communication infrastructure for thecomputers and servers. Active and passive RFID sensors 14 may beemployed. The active sensors 14 (RFID) may have a two-way communicationfunction, which allows the base computer system to dynamically managethe sensors 14; vary update rates; send self-identification andtelemetry data.

The active sensors 14 may employ dual-radio architecture. In oneembodiment, active sensors 14 transmit radio pulses, which are used todetermine precise two-dimensional or three-dimensional location and aconventional bi-directional radio, which is used as a control andtelemetry channel with a sensor update rate.

The user monitoring device 10 gathers telemetry data, communicates thatdata to a base station, BLUETOOTH® enabled device, or smart phone andthe like. From the base station, the user monitoring device 10 canreceive firmware updates or via a BLUETOOTH® enabled device. The usermonitoring device 10 can receive updates wirelessly. The base stationcan receive firmware updates from Network Systems, take telemetry datafrom the user monitoring device 10 and transfer it to Network Systems.Telemetry data received from the base station is analyzed by servers andpresented to an end user. Any third party device can receive data fromthe user monitoring device 10 wirelessly and deliver information to theservers for processing.

In one embodiment, the user monitoring device 10 uses an accelerometer,gyroscope, GPS sensor, a BLUETOOTH® chip, and a heart rate monitor.

As a non-limiting example, for heart monitoring, the accelerometer,sensor 14, determines when to sample the sensors 14 and to improve theaccuracy of the heart rate monitor. The gyroscope detects movement andorientation and the GPS sensor is used to determine location of theuser. A BLUETOOTH® chip allows the device to connect wirelessly to otherthird party devices.

As a non-limiting example, a heart rate monitor 14 detects the user'sheart rate in order to accurately determine the user's activity level,behavioral patterns and the like.

An Artificial Intelligence (AI) or Machine Learning-grade algorithms isused to identify the user's activities, behaviors, behaviors and performanalysis. Examples of AI algorithms include Classifiers, Expert systems,case based reasoning, Bayesian Network Systems, and Behavior based AI,Neural networks, Fuzzy systems, Evolutionary computation, and hybridintelligent systems. A brief description of these algorithms is providedin Wikipedia and stated below.

Classifiers are functions that can be tuned according to examples. Awide range of classifiers are available, each with its strengths andweaknesses. The most widely used classifiers are neural networks,support vector machines, k-nearest neighbor algorithms, Gaussian mixturemodels, naive Bayes classifiers, and decision trees. Expert systemsapply reasoning capabilities to reach a conclusion. An expert system canprocess large amounts of known information and provide conclusions basedon them.

A case-based reasoning system stores a set of problems and answers in anorganized data structure called cases. A case based reasoning systemupon being presented with a problem finds a case in its knowledge basethat is most closely related to the new problem and presents itssolutions as an output with suitable modifications. A behavior based AIis a modular method of building AI systems by hand. Neural networks aretrainable systems with very strong pattern recognition capabilities.

Fuzzy systems provide techniques for reasoning under uncertainty andhave been widely used in modern industrial and consumer product controlsystems. An Evolutionary Computation applies biologically inspiredconcepts such as populations, mutation and survival of the fittest togenerate increasingly better solutions to the problem. These methodsmost notably divide into evolutionary algorithms (e.g., geneticalgorithms) and swarm intelligence (e.g., ant algorithms). Hybridintelligent systems are any combinations of the above. It is understoodthat any other algorithm, AI or otherwise, may also be used. Examples ofsuitable algorithms that can be used with the embodiments of the presentinvention are disclosed in, EP 1371004 A4, EP 1367534 A2, US 20120226639and US 20120225719, all incorporated fully herein by reference.

In various embodiments, the user monitoring device 10 has additionalfeatures. In one embodiment, the user monitoring device 10 changescolor, via infrared LEDs, to accurately match the wearer's skin tone.This creates a seamless and more personal integration of technology intothe user's daily life. In this embodiment, there is skin contact withthe user monitoring device 10.

In another embodiment, the user monitoring device 10 remotely remindsand can be used to administer medications. As a non-limiting example,the user monitoring device 10 can inject adrenalin. In one embodiment,the user monitoring device 10 has sleep pattern recognition based onmovement and heart rate.

In various embodiments, the user monitoring device 10 uses algorithms todetermine activity type, behavioral patterns and user habits based oncollected data.

In one embodiment, the user monitoring device 10 uses the accelerometerinformation to improve the heart rate monitor. As a non-limitingexample, the user monitoring device 10 detects movement and speed.Addition of this data improves the accuracy of the heart rate monitorand corrects for any miscalculations in vibration, noise and skin color.

In one embodiment, velocity readouts and accelerometer data are used tomeasure when to sample heart rate. For example, if the user monitoringdevice 10 registers zero velocity readout, the user is probably at restor engaged in a passive activity. Thus, the user monitoring device 10knows not to sample heart rate. This results in conversation of time,energy and data storage.

User activity, performance and action can be based on the accelerationand angular velocity of the user monitoring device 10. In oneembodiment, the user monitoring device 10 has a feature where the usermonitoring device 10 authorizes third party interaction based on handgesture, on previous interactions or patterns of behavior. As anon-limiting example, if one purchases a coke every day for the last twoweeks, the user monitoring device 10 can “orders” the person another onebased on the prior history.

In one embodiment, the user monitoring device 10 features near-by usermonitoring device 10 recognition that provides for other user monitoringdevice 10 devices to be recognized within a particular vicinity and areable to share and transfer data between them. The user monitoring device10's data analysis and feedback can be based on current or previoussensor output. The user monitoring device 10 can alert the user when tocharge the user monitoring device 10 and when it is the most convenientfor the user.

In one embodiment, the user monitoring device 10 provides feedback viacolor change. An outer shell of the user monitoring device 10 can usevisual feedback, including but not limited to pigment or color changesto indicate changes in user behavior or to prompt changes in userbehavior. In one embodiment, the user monitoring device 10 is flexiblein shape. As a non-limiting example, if the user puts the usermonitoring device 10 over their hand it can expand or contract, morphingto change size and shape.

In one embodiment, the user monitoring device 10 can have a sync featurefor multiple bands at the same time.

In one embodiment, the user monitoring device 10 has data transfer to anexternal device that can be included or not included in system 32.Patient monitoring device 10 could be a data leaching device. Forexample, the user can relay information to someone else's device(intermediary device) to access Network Systems connected device.

In one embodiment, the user monitoring device 10 can disable therecording of one or more sensors 14 based on location, acceleration (orlack thereof) and the like.

In one embodiment, the user monitoring device 10 detects different typesof transportation and activity based on sensor data. In one embodiment,user monitoring device 10 can unlock doors or cars. The user can turn iton and off. As a non-limiting example, it can be turned off by having acapacitor switch on top and bottom and is placed in a way that onecouldn't accidentally turn it off. As a non-limiting example, turning itoff can be done by rotating the user monitoring device 10 once.

In one embodiment, the user monitoring device 10 recognizes the wearerbased on biometric information, previous data, movement pattern, and thelike. In one embodiment, the user monitoring device 10 detects a newuser based on an inability to match to user/usage patterns.

As non-limiting examples, a variety of different sensors 14 can be usedsuch as, an altimeter, blood oxygen recognition, heart rate from wristvia sonar, Doppler, based on sound wave and movement, based on pressure,and the like. A pressure sensor 14 can be placed on a circulatory vesselsuch as a vein to detect pulse.

With the user monitoring device 10 of the present invention, mechanicalactions of the user can be triggered, recognized and evaluated.

As a non-limiting example, with multiple users and wearable devices 10,a separate user monitoring device 10 ID is assigned to each of the usersA, B AND C, and thereafter the assigned transmitter/monitor 14 generatesuser activity data and/or user tracking data. For purposes of thisdisclosure, monitoring data is defined to include data acquired duringthe process of monitoring or evaluating a predefined characteristic. Theuser activity data tracks data from the sensors 14 is transferred to thereceivers 34 via the wireless connections 38 represented by a dashedline.

A network of receivers 34 transfers the user activity and/or trackingdata to system server 16 via connection 50. System server 16 includes aprocessor 52 configured to process the user data in a known manner. Forexample, the processor 52 may convert raw user data acquired by thesensors 14 into more conveniently readable data.

As a non-limiting example, the display 42 can be implemented tographically convey user information from system server 16 in aconveniently readable manner. As a non-limiting example, the user may bea cardiac user with user monitoring data graphically conveyed as aconventional ECG plot comprising a sequence of P-waves, a QRS complexesand a T-waves. As another example, user tracking data may be graphicallyconveyed as an icon superimposed onto a map to indicate the user'srelative location. Alarm 44 may be included in this embodiment.

In some embodiments, system 32 ID circuitry delivers a unique ID to thewearable device from database 18. BLUETOOTH® chips can be coupled withother wearable devices 10 in the area. This data is then stored, as morefully explained in the following paragraph. The unique ID can beutilized for a variety of different applications including but notlimited to payments, social networking and the like.

The ID circuitry of system 32 can include a number of system/components:unique ID storage, communication system, which reads and transmits theunique ID from the unique ID storage, battery 24 or power system thatprovides power to enable communication with the user monitoring device10, a pathway system to route signals to through the circuitry, acluster that crunches information, and a control system, to orchestratethe communication between different systems. All of these systems can beimplemented in hardware, software or a combination thereof. Continuingwith the telemetry system 32, sensors 14 and sensing devices aredisposed on wearable devices 10 worn by users. Data, such as movement,location, speed, acceleration, and the like, can be acquired, capturedand provided to system 32.

System 32 and an associated Network System can include an identificationreference, including user activity, performance and referenceinformation for each individual sensor 14 and location.

The user activity, performance metrics, data and the like captured bysystem 32 can be recorded into standard relational databases SQL server,and/or other formats and can be exported in real-time.

In various embodiments, the user monitoring device 10 and/or system 32are fully sealed and have inductively charges. All communication is donewirelessly.

In one embodiment, there are no electrical contacts, physical contactsor connections with the user monitoring device 10. The user monitoringdevice 10 is seamless. The telemetry system 32 can include amicroprocessor with CPU 20, memory, interface electronics andconditioning electronics 33 configured to receive a signal from thesensors 14. In one embodiment, all or a portion of the conditioningelectronics 33 are at the user monitoring device 10.

In one embodiment, the CPU 20 includes a processor 52, which can be amicroprocessor, read only memory used to store instructions that theprocessor may fetch in executing its program, a random access memory(RAM) used by the processor 52 to store information and a master dock.The microprocessor is controlled by the master clock that provides amaster timing signal used to sequence the microprocessor 52 through itsinternal states in its execution of each processed instruction. In oneembodiment, the microprocessor 52, and especially the CPU 20, is a lowpower device, such as CMOS, as is the necessary logic used to implementthe processor design. The telemetry system 32 can store informationabout the user's activity in memory.

This memory may be external to the CPU 20 but can reside in the RAM. Thememory may be nonvolatile such as battery backed RAM or electricallyerasable programmable read only memory (EEPROM). Signals from thesensors 14 can be in communication with conditioning electronics 33 thatwith a filter 35, with scale and can determine the presence of certainconditions. This conditioning essentially cleans the signal up forprocessing by CPU 20 and in some cases preprocesses the information.These signals are then passed to interface electronics, which convertsthe analog voltage or currents to binary ones and zeroes understood bythe CPU 20. The telemetry system 32 can also provide for intelligence inthe signal processing, such as achieved by the CPU 20 in evaluatinghistorical data.

In one embodiment, the actions of the user wearing the user monitoringdevice 10 with the unique ID can be used for different activities andcan have different classifications at system 32.

The classification can be in response to the user's location, where theuser spends it time, with which the user spends its time, determinationof working relationships, family relationships, social relationships,and the like. These last few determinations can be based on the time ofday, the types of interactions, comparisons of the amount of time withothers, the time of day, a frequency of contact with others, the type ofcontact with others, the location and type of place where the user isat, and the like. These results are stored in database 18.

In one embodiment, the user wearing the user monitoring device 10 canaccess this information from any place where data is presented to theuser, including but not limited to mobile devices, the WEB, applicationsprogram identifiers, and the like.

As a non-limiting example, the user monitoring device 10 communicateswith a base station at system 32. The user monitoring device 10 canintelligently switch between data transfer and charging based on sensorreadout. The user monitoring device 10 can represent data based onconnected devices.

In one embodiment, the user monitoring device 10 has the capability ofproviding recommendations, popularity of locations or activities basedon acquired data from the user.

In one embodiment, the user monitoring device 10 has the capability ofintroducing the user to other people or users based on their data andthe user's data.

In one embodiment, the user monitoring device 10 can determine emotionof the user.

In one embodiment, the user monitoring device 10 uses incremental datatransfer via BLUETOOTH® and the like. The user monitoring device 10 cantransmit data through the inductive coupling for wireless charging. Theuser is also able to change the frequency of data transmission.

The user monitoring device 10 can engage in intelligent switchingbetween incremental and full syncing of data based on availablecommunication routes. As a non-limiting example, this can be viacellular Network Systems, WiFi, BLUETOOTH® and the like. In oneembodiment, the user monitoring device 10 has data storage. As anon-limiting example, storage of telemetry data on user monitoringdevice 10 can be amounts up to about 16 mg.

In one embodiment, data transferred if it's in a selected proximity of abase station of system 32 or in proximity of an associated connectedNetwork System. In one embodiment, the user monitoring device 10 has adynamic change of data capture frequency. The user monitoring device 10can be programmed to instantly change how often it samples any sensor 14based upon the sensor data. Intelligent data sampling is based on sensorreadout.

The user monitoring device 10 can receive firmware updates via a basestation 110 of system 32. In one embodiment, the user monitoring device10 presents analyzed data and feedback on a website. In one embodiment,the user monitoring device 10's software is based on unique humanmovement. The user monitoring device 10 is able to identify its wearerbased on the unique patterns of movement, location check-ins and dailyhabits of the user.

In one embodiment, the app can be used on a mobile device, including butnot limited to a smart phone and the like.

In one embodiment, a breakdown of recounting data that has beencollecting is presented for analysis of that data. Observation orrecommendations can be presented based on historical information andlive information. The importance of the data can be based on past userbehavior.

In one embodiment, the user monitoring device 10 has artificialintelligence. A wearable device processor 54 implements logic resourcesthat exist on user monitoring device 10.

In one embodiment, user monitoring device 10 engages in the routing ofuser information to third parties based on predefined rules, based onsystem 32 analysis.

In one embodiment, user monitoring device 10 includes one or moreprocessors 54 that implement intelligent algorithmic processing andtransfer of information to third parties. Feedback can be provided tothe end user that is based on visual, tactile, gesture information andthe like.

The ID can be sent from the user monitoring device 10 in a variety ofdifferent transmit modes, which may be provided as part of the firmwareor software of an ID or sensor transmitter 14, and which may be utilizedselectively during the operation of said sensor transmitter 14, mayinclude ‘burst” transmit modes, wherein a burst of data information istransmitted, or “parcel” transmit modes, wherein timed data packets ofdata, which may, as desired, comprise partial data strings, aretransmitted, and, if desired, repeated during time intervals. Further,the sensors 14 may have programmed therein diagnostic routines or othertest modes which assist during manufacture and use, providing theoperator with operational status and verification information on saidsensor/transmitter 14, as needed. Referring to FIG. 4, system 32includes data base 18 which contains the desired transmitter, sensor, 14personality data, as well as, the address/device ID bits for each usermonitoring device 10.

In one embodiment, the initial programming of the user monitoring device10 for the ID, as well as optionally other personal information of theuser, is done securely, as unauthorized future alteration of samethereafter can be utilized as a means of violating system integrity.

In one embodiment, an inductive field coil is used for programming thesensors 14 and ID of user monitoring device 10.

As illustrated in FIG. 4, the user monitoring device 10 can include asensor 14 with an output that be received by an amplifier 56 and decodedby an I/O decoder 58 to determine 1/0 logic levels, as well as, bothclock and data information 60. Many such methods are commonly availableincluding ratio encoding, Manchester encoding, Non-Return to Zero (NRZ)encoding, or the like; alternatively, a UART type approach can be used.Once so converted, clock and data signals containing the informationbits are passed to a memory 62. Any of these connections provides alogical link from the system's database 18 to the sensor 14, ID of theuser monitoring device 10, as shown in FIG. 5.

In one embodiment, illustrated in FIG. 5, the system 32 chooses thenecessary programmable sensor functions and stores them into database18. In one embodiment, in order to insure that an unauthorized usercannot connect into and program user monitoring device 10 the followingprocedure may be used:

Both the sensor 14 and receiver 34 contain an identical, repeatablepseudo randomization algorithm in ROM or in ASIC logic.

Referring to FIG. 6, the algorithm is applied to outgoing programmingdata 64 from system 32 and produces a number of security/randomizationbits 66 that can be appended to the outgoing programming message ormessage 68 and sent to a sensor 14.

Referring to FIG. 7 the sensor 14 likewise applies this pseudorandomization algorithm as the security/randomization bits 66 to theoutgoing programming data, now forming the incoming programming data 70to sensor 14 and produces a several bit result in the shift register 71.The scrambling algorithm is devised such that a small difference in theprogramming bit stream causes a great difference in the pseudorandomization result. As a non-limiting example, the present inventioncan use a 16 bit polynomial to produce this pseudo randomization.

Optionally, in one embodiment, before a sensor 14 accepts thisprogramming, stored in an address and personality register 73, both thepseudo random code, stored in data in a shift register 75 from system 32and a sensor 14, in a shift register 71 must match via a comparator ID,77, indicating unauthorized acceptance use. In addition to insuringauthorized access, this process also insures that the data itself iscorrect. The longer the polynomial sequence used, the greater thesecurity.

In one embodiment, spread spectrum or other RF transmission is used andcan include programming to determine that the frequency or spreadspectrum code is unique to the area. If a spread spectrum code, systemcode, or frequency channel is found to be occupied at a future time ofuse. Re-programming of the user monitoring device 10 is then done with anew, unused spread spectrum code or system code or frequency channel canbe selected, or, in the alternative, CPU 20.

As illustrated in FIG. 5, step “E” would include, for example, the stepof the sensor 14, inputting the programming message and saving a seed inmemory 62; with the sensor 14 utilizing the seed to code digital databits transmitted.

As illustrated in FIG. 8, the location of a user monitoring device 10with the ID and sensors 14 can be determined. As a non-limiting example,in one embodiment the user monitoring device 10 includes a sensor 14that can provide a position signal having positioning data (e.g., rawGPD data or pseudo ranges) and the ID is transmitted from the usermonitoring device 10 to system server 16. Server 16 receives theposition signal and analyzes the signal to generate informationrepresenting the location of the user monitoring device 10. Server 16transmits this location information to a client computer where thelocation of the user monitoring device 10, allowing a user to identifythe location of the remote sensor 14.

In one embodiment, the position signal transmitted by the remote sensor14 can also include an emergency code. For example, in the event of anemergency, such as a medical emergency or otherwise, a user may press a“panic button” that can be on the user monitoring device 10 or by use ofa user's mobile device. Pressing the panic button may cause mobiledevice 74 to transmit an emergency signal to a cell site 76 where theemergency signal is relayed to server 16. In response, server 16 cantransmit Doppler information regarding in-view satellites, a fix commandand a time trigger signal to the user monitoring device 10.

When the location of the user monitoring device 10 has been determined,software running on server 16 configures server 16 such that a call orother signal is sent to a local emergency operator in the vicinity ofremote sensor 14. When the call or signal is received at the emergencyoperator station, the location of remote sensor 14 is transmitted anddisplayed. In some cases, where separate panic buttons are available foridentifying medical, police, fire or other types of emergencies, thenature of the emergency is also displayed for the emergency operator.Based on this information, the emergency operator can initiate anemergency response by providing the location of remote sensor 14 to therequired emergency service (police, fire department, ambulance service,etc.). In other embodiments, instead of or in addition to a positionreport for the remote sensor 14, the emergency operator may also beprovided with information which identifies an emergency response vehiclein close proximity to remote sensor 14.

As illustrated in FIG. 9, a sensor 14 of the user monitoring device 10can include a SNAPSHOT GPS receiver 72. As described above, sensor 14uses information transmitted from separately located base station 110,mobile devices, computers, and other devices, to assist in determiningthe position of the remote sensor 14, as more fully disclosed in U.S.Pat. No. 6,661,372, incorporated herein by reference.

As non-limiting examples, and as illustrated in FIG. 10, the sensors 14can be a thermal transducer 78, an acoustic transducer 80, and amagnetic transducer 82. It will be appreciated that the presentinvention is not limited the transducers 78, 80, and 82 in the usermonitoring device 10 can communicate with a microprocessor 84 alsolocated in the user monitoring device 10. The user monitoring device 10can communicate with other devices via an RF transceiver 86, an IRDAtransceiver 88, and/or an RF backscatter transceiver 90. Each of thecomponents in the user monitoring device 10 receives power as necessaryfrom the battery 24, which may include the rechargeable battery.

The acoustic transducer 80 may include a microphone, a low-pass filter,a gain amplifier, and a threshold comparator. The acoustic transducer 80may include an omnidirectional microphone, although any other suitableacoustic transducer device would suffice. The microphone may be asurface mount MEMS device that has a frequency range of 100 Hz to 10kHz. A single MCP602 operational amplifier is used on the acousticsensor to amplify and low-pass filter the acoustic signal from themicrophone. Another operational amplifier is used to generate a voltagereference used for single biasing and detection. The microphone outputis biased to the midway point between the circuit supply voltage andground to allow for both positive and negative signal swings. The biasedsignal is filtered with a second order low-pass Butterworth filter toremove upper frequency noise. It is then amplified with an adjustablegain that is controlled by a digital resistor potentiometer. Thisdigital resistor operates on an I2C bus and is controlled by themicroprocessor 84. Lastly, the amplified acoustic signal is thresholddetected against a static voltage to detect sufficiently large acousticsignals. The digital output of the threshold detector is connected tothe microprocessor 84 for processing.

The magnetic transducer 82 can include a magnetic sensor integratedcircuit, a differential instrumentation amplifier, a low-pass filter,two gain amplifiers, and a threshold detector. The magnetic transducer82 may include an NVE AA002-02 GMR (giant magneto resistive) fieldsensor, although any suitable magnetic sensor would suffice. This sensorhas a saturation field of 15 Oe, a linear range of 0 to 10.5 Oe, and asensitivity of 3 mV/V/Oe. Two MCP602 CMOS operational amplifiers areused on the magnetic sensor to amplify and low-pass filter the analogoutput signal. An INA122UA instrumentation amplifier is used as adifference amplifier for the differential output from the magneticsensor. The magnetic sensor IC can be based on Spintronics technology.Its output includes a differential voltage pair proportional to thedetected magnetic field. The differential voltage pair is amplified andconverted to a single voltage by the instrumentation amplifier. TheAC-coupled signal is then amplified and filtered with a low-pass filterto remove upper frequency noise and boost the low-voltage signal output.The signal is amplified a second time by an adjustable gain controlledby a digital resistor similar to the acoustic sensor. Lastly, theamplified magnetic signal is threshold detected against a staticvoltage, to detect sufficiently large changes in magnetic fields. Thedigital output of the threshold detector can be connected to themicroprocessor 84 for processing.

A DS1803E-010 digitally controlled 10 kOhm variable resistor can be usedin both the acoustic and magnetic sensor circuits. It is used to adjustthe gain of one gain stage in each circuit. The digital resistor iscontrolled through an I2C interface. A LMV393IPWR comparator is alsoused in both the magnetic and acoustic sensor circuits for determiningwhen a sufficiently strong sensor signal has been detected. It comparesthe analog sensor signal against the voltage reference and its output istied to the microprocessor 84 for data collection.

The thermal transducer 78 may include a Burr Brown TMP 100NA/250 12-bitdigital temperature sensor, although any suitable thermal sensor wouldsuffice. The digital temperature sensor has an operating range of −55 to+120.degree C., an accuracy of 0.5.degree C. and a maximum resolution of0.0625.degree C.

Even though it is a 12-bit sensor, suitable results are achieved withonly 9-bit conversions with only the 8 most significant bits used. Thesensor has an I2C interface and is normally kept in sleep mode for lowpower operation. When directed by the microprocessor 84, the thermaltransducer can perform a 9-bit temperature conversion in 75milliseconds.

The RF transceiver 86 may include an RF Monolithic DR3000 transceiver,although any suitable transceiver or separate transmitter and receiver34 would suffice. This transceiver 86 allows for both digitaltransmission and reception. The transceiver 86 can have an operatingfrequency of 916.5 MHz and is capable of baud rates between 2.4 kbps and19.2 kbps. It can use OOK modulation and has an output power of 0.75 mW.It also can use digital inputs and outputs for direct connection withthe microprocessor 84. The transceiver 86 can use an antenna 92 (FIG.11) that may include a 17 mil thick plain steel electric guitar G-stringcut to a length of 8.18 cm. It is used in a monopole over groundconfiguration and can require a matching circuit of one inductor and onecapacitor. Alternatively, Frequency Shift Keying (FSK), Quadrature PhaseShift Keying (QPSK), or any other suitable modulation scheme may beutilized.

The IRDA transceiver 88 may include a Sharp GP2W0110YPS infraredtransceiver, although any suitable IRDA compliant infrared transceiverwould suffice. This transceiver 88 can be IRDA v1.2 compliant and in oneembodiment has an operating range of 0.7 meters. In one embodiment, itis capable of 115.2 kbps data speeds.

The RF backscatter transmission device 90 may include circuitryavailable from Alien Technology (of Morgan Hill, Calif.) for receivingand transmitting signals via RF backscatter. Battery 24 may be a 3.6volt 1/2 AA lithium battery with a capacity of 1.2 amp hours. Thebattery 24 can be a power source 24 that can include a Texas InstrumentsTPS76930DBVT voltage regulator to regulate the output signal to 3 voltsand with a maximum current of 100 mA. The voltage regulator can includea LDO.

The RF backscatter transceiver 86 in the user monitoring device 10communicates with an RF backscatter reader 94 such as a class 3 readerfrom Alien Technology. The reader 94 transmits data to the backscattertransceiver 90 of the user monitoring device 10 by broadcasting encodedRF pulses and receives data back from the transceiver 86 by continuallybroadcasting RF energy to the sensor 10 and monitoring the modulated RFreflections from the sensor 10.

The RF backscatter transceiver 90 can include a printed circuit board(PCB) patch antenna for RF reception, and RF modulation, a Schotky diodedetector circuit, a comparator circuit for signal decoding, and a logiccircuit for wake-up. The logic circuit monitors the incoming data, andwhen an appropriate wake-up pattern is detected, it triggers themicroprocessor 84 so that data reception can begin. In one embodiment,the reader 94 has an operating frequency between 2402 MHz and 2480 MHz,and uses frequency hopping in this band to reduce noise interference. Amodulation method used by the reader 94 can be On-Off Keying (00K). Inone embodiment, the transmission power is 1 watt. The operation of thereader 94 may be controlled by an external computer (not shown) asdirected by Labview software via a RS-232 serial link.

The RF transceiver 86 can communicate with an external RF transceiver 96such as a DR3000 transceiver from Radio Monolithics, Inc. In oneembodiment, it operates at 916.5 MHz, uses OOK modulation, has acommunication range of 100 meters line of sight, and a baud rate of 19.2kbps. The active RF antenna 92 can be a quarter-wavelength monopole madefrom a guitar G-string and appropriate matching circuitry. Two controllines from the microprocessor 84 can be used to select the mode ofoperation, choosing from transmit, receive, and sleep. The active RFreceiver 34 consumes the most power in receive mode compared to theother two communication links.

FIG. 6 shows the relative positioning and shape of the active RF antenna92 and the RF backscatter antenna 98.

The IRDA transceiver 88 of the user monitoring device 10 can communicatewith an external IRDA transceiver 100 that may be identical to the IRDAtransceiver 88. Alternatively, the IRDA transceiver 100 can be one suchas is provided in most personal digital assistants (PDA) as well as manyother consumer devices. The IRDA communication link follows the standardIRDA signal and coding protocol and is modeled after a standard UARTinterface. In one embodiment, the IRDA transceiver 88 is capable of dataspeeds less than 115.2 kbps, and may only have a range of 0.7 meters fortransmission. One advantage of the IRDA communication link is that itdoes not require any of the RF spectrums for operation, but it typicallydoes require line-of-sight communication.

When any one of the transceivers 86, 88 and 90 on the user monitoringdevice 10 detect the beginning of valid data on their respectivecommunication link, all other transceivers are disabled, therebypreventing the corruption of incoming data with the noise or partialdata packets on the other communication links. However, if the data onthe active transceiver proves to be erroneous, the other transceiverswill be re-enabled if appropriate to allow normal operation to continue.If the data received by the active transceiver is valid, however, theother transceivers will remain disabled for several hundred millisecondslonger in the high probability that the next data packet will betransmitted on the same communication link. If, after this extendeddelay, no additional packets are received, then the other transceiverswill be re-enabled as appropriate.

In one embodiment, the active RF protocol has no wake-up orsynchronization packets, and the packets sent to and from the sensor areidentical. In one embodiment, the format of an active RF packet is shownin FIG. 16. It can include a preamble to reset and spin-up the statemachine of the RF receiver 34 and to properly bias the receiver's 34data slicer/threshold detector for optimum noise rejection and signalregeneration, two framing bits to indicate the beginning and end of thedata bytes, and the data bytes themselves.

Furthermore, the encoding scheme for the three symbols is shown in FIG.12. The entire packet is DC balanced to maintain an optimal level on thedata slicer/threshold detector and the receiver 34. Data is sent mostsignificant bit first.

The IRDA communication link can follow the standard IRDA protocol forbit encoding and UART protocol for byte transmission. Packetstransmitted on the IRDA link can contain no preamble or framing bits,but they do have a header that contains two bytes. The first byte is anASCII “I” which denotes the beginning of a valid IRDA packet. The secondbyte equals the number of preceding bytes in the packet. This value isused by the receiver 34 to determine when the entire packet has beenreceived and processing of information can begin. The packet structureis shown in FIG. 13 and the IRDA/UART encoding scheme is shown in FIG.14.

The data bytes contained in a packet transmitted to the sensor 10through any of the communication links conform to a packet format. TheCMD section of a packet is a single byte that identifies the type ofpacket being sent. The CMD byte appears above the beginning and end ofthe packet and the two must be identical. The reason for including theredundant byte is to further eliminate the chance of a packet's CMDidentifier being corrupted at the receiver 34, even if the CHECKSUM iscorrect.

The PAYLOAD contains all of the data that must be sent to, or returnedfrom, the sensor. The PAYLOAD is broken down into individual bytes withthe overall number of bytes and their content dependent on the type ofpacket being sent.

The CHECKSUM is a 16-bit CRC that is performed on all bytes in the datapacket excluding the end CMD byte in packets generated by the externaldevice. The CHECKSUM is sent most significant byte first.

The transceivers 86, 88 and 90 may be required to communicate over agreater distance than do the components described herein. Upgradingthese components to be suitable for longer distance transmission isconsidered to be within the spirit of this invention. The type oftransducer is not limited to the specific transducer types describedherein. In addition, the logic described herein for arbitrating betweenwhich communication device to use to communicate with the outside worldand which sensor data to provide at what time is but one possibleapproach to arbitration logic within such a remote sensor 10.

In one embodiment, illustrated in FIG. 15, an activity manager 218 isprovided that is used for managing lifestyle activities of the user.Activity manager 218 can be a standalone device, or as part of thetelemetry system 32 or monitoring device 10. The dynamic activitymanager 218 can associate one or more contexts such as time, location,and the like to an activity entered by a user. The dynamic activitymanager 218 also manages an activity and any device or item associatedwith the activity.

In one embodiment, one or more of sensors 14 can be a lifestyle sensor.For example, the sensor 14 can be a physiological sensor such as a heartrate sensor, body temperature sensor, caloric sensor, or the like.Another example of a sensor is a pedometer. It should be noted that anysensor or device capable of taking measurements is applicable to thepresent invention. These sensors can be embedded, for example, inclothing and/shoes or can be stand-alone items. One specific example ofthese types of sensors is a sensor that is embedded in running shoes. Asa user walks or runs, the sensor 14 monitors various functions such asspeed, stride length, body functions (heart rate, temperatures,hydration, and the like), and the like.

This information can then be relayed back to the dynamic activitymanager 218 if desired. A web service 224 can be any type of servicesubscribed to by the user over the Internet. For example, a user can besubscribed to a weather service that is used by the dynamic activitymanager 218 when monitoring an activity such as running. The dynamicactivity manager 218, identifier enable items, including but not limitedto RFID enabled items 220, sensors 14, and Network System 224 arediscussed in greater detail below.

The dynamic activity manager 218 provides management for managing userlifestyle activities and is preferably included as part of the telemetrysystem 32. In one embodiment, the activity manager 218 is incommunication to a user interface 202, which can be at the monitoringdevice 10, for allowing a user to enter information associated with anactivity that the user wants managed and/or monitored. As a non-limitingexample, FIG. 17 shows one example of the user interface 202 beingdisplayed on the monitoring device 14. It will be appreciated thesensors can generate this information and communicate it with telemetrysystem. It should be noted that some fields can be automaticallypopulated based on user activity entry, activity history, rules, or thelike.

In one embodiment, a name entry field 302 can be used that allows theuser to enter the name of an existing activity or the field 302 can be adrop down box including existing activities. In another embodiment, themonitoring device 10 or the telemetry system 32 can perform thisactivity and function.

FIG. 16 show that a user has entered the activity of “running”.Therefore, the user is configuring the activity manager 218 to manageand monitor a running activity. The user interface 202 can also includean activity description field 304, which allows a user to enter adescription of the activity. A date entry field 306 is also included onthe user interface 202. The date field 306 allows a user to enter thedate or dates when the activity is to occur. A time start field 308 andan end time field 310 are also provided in the user interface 202. Thestart time field 308 indicates when the activity begins and the end timefield 310 indicates when the activity ends.

A user may also want the activity manager 218 to track specific itemsassociated with the activity. For example, with respect to the runningactivity, a user may want to have her running shoes and headphonestracked to ensure that she has these items when she begins the activity.This information can be entered in the items to be tracked field 312.The tracking process is discussed in further detail below. The user mayalso want to use specific sensors 14 during the activity such as sensors14 in the running shoes and a heart rate monitor. The sensor IDs ornames can be added into the sensor field 314. A user can also configurethe sensor parameters that she wants used during the activity.Alternatively, the sensor parameters can be transparent to a user. Forexample, the parameters can be pre-populated based on success of datacollection of prior activity history. This information is entered in asensor parameter field 316. In addition to having items tracked andsensors 14 monitored during the activity, the user may want to associatea web service with the activity.

For example, a user may want to associate a weather service with therunning activity so that the activity manager 218 can automatically anddynamically adjust settings on the sensors 14; determine to trackdifferent items; and the like. For example, the activity manager 218 canmonitor the web service to determine if the weather is sunny, cloudy,raining, or the like. If the weather is sunny, the activity manager maydetermine that a first pair of running shoes, sun glasses, and the likeneed to be tracked. On the other hand, if the weather is raining, theactivity manager 218 can determine not to track sunglasses and to tracka second pair of running shoes. It should be noted that the term“tracked” as used throughout this discussion refers to use of the ID ofthe monitoring device.

Alternatively, a user can setup rules that allow a web service toperform a function based on contexts. For example, if the weather israiny, a user can have a rule setup that has a web service make areservation at an indoor track. FIG. 16 also shows a web sensor rule(s)entry field 320. The web service field 320 allows a user to entervarious rules associated with Network Systems. For example, a user cansetup a web service via the web service rules field 320 to reserve arunning track if the temperature outside is less than 60° F. or if it israining.

It should also be noted that the user interface of FIG. 16 is only oneexample of a user interface applicable to the present invention. One ormore fields may be added or deleted. For example, the user interface 218can also provide a mechanism to a user for reviewing all enteredactivities, deleting activities, and the like. It should also be notedthat the user interface 202 can also reside on an information processingsystem coupled to the monitoring device 14. For example, the activitymanager 218 can have software loaded on a personal computer that allowsthe user to enter the above information or to interact with the activitymanger 218. The activity manager 218 can then sync with database 18 toupdate its data. In yet another embodiment, a user can enter informationdirectly at an identifier enabled item 220 or a sensor 14. For example,a sensor 14 can include a user interface with a calendar. Anyinformation entered here can then be synced with the activity manager216. Any configuration parameters such as a heart rate baseline, stridelength, and the like are then communicated to the activity manager 218.

Referring again to FIG. 15, the information received from a user, forexample, via the user interface 202 can also be provided to a calendar204 residing within the monitoring device 14. Alternatively, informationfrom the calendar 204 can also be extracted by the activity manager 218.For example, if the activity manager 218 determines that a user hasentered a new activity in the calendar 204, the activity manager 218 canprompt the user to determine if the user wants the activity manager 218to monitor and manage that activity. Although shown residing outside ofthe activity manager 218, the activity manager 218 can include aninternal calendar for monitoring lifestyle activities. In other words,the monitoring device 14 can include a calendar and the activity manager218 can also include an internal calendar used in conjunction with thewireless device calendar 204.

Based upon the received activity information, the activity manager 218creates activity profiles 210, 212 that are stored in an activitymanagement database 208. FIGS. 17( a) and (b) shows an example of anactivity profile 210 for a variety of activities. Although FIGS. 17( a)and (b) show a single table that includes multiple activities, eachactivity can be stored within a separate activity profile. FIG. 18 alsoshows a calendar 204 comprising calendar events associated with anactivity. The activity profile 210 includes various informationassociated with an activity such as a name 404 of an activity, anactivity ID 406, a sensor or device name 408 associated with theactivity, an identifier/device IP address 410 if available, dataconfiguration 412 for the sensor/device and the like.

Also, FIGS. 17( a) and (b) show Network Systems 414 and web servicerules 416 associated with a web service. For example, a web service A isassociated with the “running” activity. A web service rule is associatedwith the web service A that indicates that if the temperature outside isless than 60° F. then reserve an indoor track. As can be seen, theactivity profile associates a sensor/device context with activity. Thesensor/device context indicates what sensors 14/devices or associatedwith the activity and their current configurations.

In the example of FIG. 18, the information within the activity profile210 is independent of a time context or location context associated withan activity. In one embodiment, the calendar 204 associates a timecontext with and activity and an optional location context. For example,FIG. 18 shows a calendar event 402 set for May 2nd with a “running”activity from 2 p.m. to 3 p.m. The calendar 204 can also show thelocation of the activity such as “Millennium Park”. Therefore, the“running” activity has a time context and a location context associatedwith it. The information within the activity profile 210 can be used bythe activity manager 218 regardless of the time and location contexts.

For example, if the user has defined a “running” activity on twodifferent days at two different times and at two different locations,the activity manager 218 can still refer to the “running” activityprofile and use the information included therein for the two instancesof the “running” activity. Therefore, the activity manger 218 monitorsboth the calendar 402 and the activity management database 208. However,the activity profiles 210 can also include time and location contexts aswell. In this example, a separate activity profile is stored in theactivity management database for each instance of an activity.

Returning now to FIG. 16, the activity manager 218 also includes acontext monitoring module 210. In one embodiment, the content monitoringmodule 210 allows the activity manager to determine whether an activityis about to start, has started, or has ended and either monitor foridentifier enabled items 220 and/or initialize sensors 14 associatedwith the activity. For example, the context monitoring module 210monitors context such as time, location, device, and the like. Thecontext monitoring module 210 can monitor the calendar 204, GPS, orinformation entered by the user to determine the current and/or locationof the wireless device. The activity manager 218 can compare activityprofiles and/or calendar events with the determined time and/or locationto determine whether an activity is starting, ending, or the like.

In one embodiment, the dynamic activity manager 218 is communicativelycoupled to a GPS module 246 and a display 244. The GPS module can beused by the dynamic activity manager 218 to determine the location ofthe monitoring device 14. The display 244 can be used for, among otherthings, to display data/information, visual alerts to a user.

As discussed above, the activity manager 218 manages and monitorsidentifier, enabled items 220, sensors 14, and Network Systems 224associated with a user activity. The identifier enabled items 220 can beany item that is coupled to an identifier or other communication tag.The activity manager 218 monitors identifier enabled items 220 via anidentifier enabled item monitor 206, herein referred to as the“identifier monitor” 206. The identifier monitor 206, in one embodiment,can be an identifier transceiver embedded with monitoring software orcan be a separate monitoring software module coupled to an identifiertransceiver.

The identifier monitor 206 can be configured by the user toautomatically start monitoring for items associated with an activity orto continuously monitor for identifier enabled items 220. For example,when the activity manager determines, based on a time context and/or alocation context associated with an activity, that it is time for anactivity to start, the activity manager 218 can begin monitoring forassociated identifier enabled items 220. For example, if the activitymanager 218 determines that the running activity is about to begin, theidentifier monitor analyzes the activity profile 210 to determine whatitems are needed for the activity. The identifier monitor 206 thendetermines if items such as running shoes and heart beat monitor arepresent. In other words, the identifier monitor 206 determines if anidentifier signal from the running shoes and the heartbeat monitor hasbeen detected. The activity manager 218 can then visually, audibly,and/or tactilely notify the user of the presence or non-presence of theitems 220.

Based on the activity profiles 210, calendar 204, and/or an internalclock the activity manager 218 can determine that the user has not leftfor work, to go running, or whatever the activity may be. For example, auser can have a calendar entry or an activity defined for “leave forwork”, which begins at 8:00 a.m. Therefore, if the time is 7:30 a.m. theactivity manager 218 can determine that the user has not left for work.In another example, a user can have an activity defined for “running”.The activity manager 218 can detect that the user has left the house,entered his/her car or the like either by passing an identifier sensorat a door or via GPS and analyzes the activity profiles 210 accordingly.

The activity manager 218, based on activity profiles and/or calendarevents determines that the user is going straight from work to herrunning activity. Therefore, the activity manager 218 monitors for theitems associated with the running activity. The activity manager 218then notifies the user if these items have been protected

In addition to monitoring for associated identifier enabled items 220when an activity is to begin, the activity manager 218 manages sensors14 associated with the activity. For example, when an activity is aboutto begin, the activity manager 218 analyzes the activity profile 210associated with the activity and identifies the sensors 14 associatedwith the activity. If the sensor 14 has not been initialized, theactivity manager 218 initializes the sensor 14 using the configurationparameters in the activity profile 210. For example, the sensors 14 andthe monitoring device 14 can communicate via a communication manager 212within the activity manager 218. The sensors 14 and the monitoringdevice 14 can communicate using a wireless connection such asBLUETOOTH®, Zigbee, or the like. In one embodiment, the dynamic activitymanager also includes a data fusion module 214 for performing datafusion with respect to health and fitness information monitored by thesensors 14.

FIG. 18 shows a timing diagram for one example of initializing a sensor14 based on the activity manager 218 detecting the start of an activity.In the example of FIG. 18, a user has a “running” activity defined onthe user's monitoring device 14 and wants to invite a friend to theactivity. At time TO the activity manager 218 sends an invite associatedwith the “running” activity to another wireless device. The inviteincludes the time context, e.g., May 2nd at 2 p.m., and can include anoptional location context. At time T1 the invitee wireless device sendsan acceptance message to user's monitoring device 14. At time T2, theactivity manager 218 determines that the time is 2:00 p.m. and queriesthe activity management database 208 to identify the sensors 14associated with the “running” activity. The activity manager 218 alsoobtains the IP address of the sensor(s) 14. The IP address is used bythe communication manager 212 to communicate with the sensor 14. In oneexample, the sensors 14 associated with the running activity are asensor within running shoes that measures average speed, distancetraveled, and the like. Another sensor can be a hear rate monitor wornin the wrist or an audio headset of the user.

At time T3 the activity manager 218 pings the sensors 14 to determine ifthey have been initialized. If the sensors 14 have not been initializedthe activity manager 218 identifies that configurations parameters ofthe sensor from the activity profile 210 and initializes the sensors 14accordingly. The sensors 14, at time T4, send a ready response to theactivity manager 218. At time T5 the activity manager 218 beginscollecting data from the sensors 14. The activity manager 218, at timeT6, determines that the activity has completed. At time T7, the activitymanager 218 displays collected data from the sensors 14 to the user viathe user interface 202.

In another embodiment, a user can configure the activity manager 218 toonly collect specific data from a sensor 14 or not all data. Also, theactivity manager 218 does not have to communicate with a sensor 14during an activity. For example, a user may have forgotten themonitoring device 10 at her house. The application manager 218determines that an activity is starting, but sensors 14 are not in thevicinity. When sensors 14 come back into range with the monitoringdevice 14, e.g., the user comes home from running, the activity manager218 queries the sensor 14 for the data collected during the activity. Inone example, the sensors 14 collect data continuously and in anotherexample the sensor 14 only collects data during scheduled activities.For example, a user's watch may have a biometric sensor that collectsdata throughout the day. However, the user may only be concerned withplotting data during athletic activities such as bicycling. Therefore,the activity manager 218 can query the sensor 14 for data only collectedduring a bicycling activity. In the above embodiments, the sensorsinclude memory for storing data.

As illustrated in FIG. 2, the activity manager 218 can also monitor andmanage Network Systems 224 associated with an activity. For example, auser can define rules associated with Network Systems 124 that are to beapplied to the activity manager 218 with respect to an activity. Oneexample is where a user subscribes to a weather service. The user candefine a rule that states if the weather is rainy during the time periodassociated with an activity, then delay any monitoring or managing forthat activity for 1 hour. Another rule can state to delay any managingor monitoring until a user prompt is received. The activity manager 218can query the web service 124 at the start or prior to an activitystarting to obtain the required information.

The activity manager 218 can also make dynamic decisions for when tomonitor and/or manage an activity. For example, a user has an activitydefined for “pick up dry-cleaning” at 3:00 p.m. However, at 12:00 p.m.the user runs errands and is approaching the dry cleaners. The activitymanager 218 can detect the location of the user via GPS and determinesthat the user is near the dry cleaners. The activity manager thendetermines that the user needs to pick up the dry cleaning and promptsthe user to pick up the dry cleaning even though the time is prior tothe 3:00 p.m. scheduled pickup time.

FIG. 19 is a block diagram illustrating a detailed view of the wirelessdevice 104 according to an embodiment of the present invention. Thewireless device 104 operates under the control of a devicecontroller/processor 602, that controls the sending and receiving ofwireless communication signals. In receive mode, the device controller602 electrically couples an antenna 604 through a transmit/receiveswitch 606 to a receiver 608. The receiver 608 decodes the receivedsignals and provides those decoded signals to the device controller 602.

Referring now to FIG. 20, monitoring device 10 and/or telemetry system32 can include a feedback system or subsystem 710 coupled to processor20 and/or 34 to communicate feedback data back to the monitoring device10. In one embodiment, the feedback system or subsystem 710 can generateand communicate closed-loop control data (“CCD”) 712 to monitoringdevice 10. For example, closed-loop control data 712 can providefeedback to the monitoring device user or patient. It will beappreciated that feedback system or system 710 can be included inmonitoring device, telemetry system 32 or be a standalone system orsubsystem.

In another embodiment, feedback system or subsystem 710 can generate andcommunicate signals 714 for video/audio data communication to themonitoring device user or patient.

In another embodiment feedback system or subsystem 710 can generate andcommunicate monitoring device user or patient control data (“PCD”) 716to the monitoring device user or patient. In another embodiment,feedback system or subsystem 710 generates and communicates sensingcontrol data (“SCD”) 718 to a feedback system 720 associated with themonitoring device 10 for providing feedback to the monitoring deviceuser or patient. Signals and data 712 through 718 can be converted intosignals for executing feedback information, visual, audio and the like,to the monitoring device user or patient.

An example of feedback system or subsystem 710 includes, but is notlimited to, a feedback engine installed as software and/or firmware onany type at the telemetry system 32. In one embodiment, the feedbacksystem or subsystem 710 is at monitoring device 10 and receives feedbacksignals from telemetry system.

FIG. 21 is a flow chart 700 illustrating one embodiment of provingfeedback and/or alerts to a user through or without monitoring device10. Flow chart 700 and other flow charts presented herein are intendedto illustrate the functional operation of the device feedback system orsubsystem 710 and should not be construed as reflective of a specificform of software or hardware necessary to practice the methodsdescribed. It is believed that the particular form of software will bedetermined primarily by the particular system architecture employed inthe device and by the particular detection and electrical stimulationdelivery methodologies employed by the device.

At block 702, user or patient feedback is detected. Examples of feedbackinclude but are not limited to lifestyle parameters, medical conditions,lifestyle events, exercise parameters, battery 24 life of the monitoringdevice 10, battery 24 replacement required, lead or sensor 14 function,pending therapy delivery, and the like. The type of feedback and alertconditions detected can vary.

At block 704, a feedback or alert is selected that is associated with adetected feedback or alert condition. Selection of a feedback or alertsignal may involve the selection of any of the above listed parameterslisted above relative to user or patient, used to control the feedbackor alert signal. At block 706 the feedback or alert signal is deliveredaccording to settings selected at block 704.

At block 708, a sensor 14 signal is measured at telemetry system 32 ormonitoring device 10, analyzed and compared to a threshold levelcorresponding to the selected alert level at block 710. An alertthreshold level may be predefined or tailored to a given monitoringdevice user or patient. If the measured sensor 14 response does notcorrespond to an expected threshold signal level or characteristicpattern of the selected feedback or alert signal, the feedback or alertsignal is adjusted at block 712 in a closed-loop feedback method untilthe sensor signal measured at block 708 falls within a desired range ofan expected threshold level, as determined at block 710. Once thedesired feedback or alert signal level is reached, the feedback or alertsignal stimulation parameters are maintained at the current settings atblock 714 to maintain the sensor signal measurement within a desiredrange of the threshold. Maintaining the feedback or alert signalresponse within a desired threshold range promotes the reliability ofthe feedback or alert signal in informing the monitoring device user orpatient of a detected parameter described above.

Determining that the sensor signal corresponds to a selected feedback oralert threshold at block 710 may involve detecting a magnitude of the asensor signal amplitude or frequency, and/or recognizing an intendedalert pattern (e.g. short-long burst sequences, strong-weak burstsequences, or the like) based on a morphology of the sensor signal. Assuch, measuring the sensor signal at block 708 may involve measuringsignal magnitude as well as frequency characteristics during thefeedback or alert signal delivery.

Additionally or alternatively, frequency characteristics of the sensorsignal may be determined to detect sensor 10 signals. The frequencypower band of the sensor may be analyzed for correspondence tofrequency, amplitude and the like. Additionally, a sensor waveform maybe evaluated for correspondence to a frequency or amplitude. Acombination of the amplitude and frequency of the sensor signal may alsobe measured to determine a monitoring device user or patient medical orlifestyle condition.

The feedback or alert signal may be terminated if a predeterminedmaximum alert duration has expired, as determined at block 716. If amaximum feedback or alert signal duration is not reached, the feedbackor alert signal may continue to be held at the current stimulationsignal settings at block 714 until the alert expires. Alternatively, theprocess may return to block 708 to continue monitoring the sensor signalthroughout the duration of the alert delivery in order to make furtheradjustments at block 712 as needed to maintain a desired strength andpattern of the monitoring device user or patient feedback or alertsignal. If the feedback or alert signal maximum duration is reached, thesignal may be immediately terminated at block 722.

In some embodiments, if a monitoring device user or patientacknowledgement signal is received prior to the maximum signal durationexpiring, as determined at decision block 718, the feedback or alertsignal is terminated at block 722. A monitoring device user or patientacknowledgment may be in a variety of forms.

In one specific embodiment, if monitoring device user or patientacknowledgement is not received or detected at block 718, the intensityof the feedback or alert signal may be increased at block 720, steadilyor in step-wise, pre-determined intervals within a feedback or alertsignal maximum duration. It will be appreciated that monitoring deviceuser or patient acknowledgement is not required. The intensity may beincreased at block 720 according to a predefined pattern by increasingpulse amplitude (up to some maximum), increasing pulse width, increasingpulse frequency or other adjustment that causes a relatively strongercontraction, i.e., greater recruitment of the muscle being stimulated.Adjusting the intensity of the feedback or alert signal at block 720 mayalso be performed using sensor signal feedback control by returning toblock 708 to compare measured sensor signal characteristics to a nexthigher feedback or alert signal threshold level. In other words, thesensor signal is compared to a different, increased intensity, thresholdthan an initial threshold in order to control the feedback or alertsignal to elicit a stronger response as compared to the initial feedbackor alert signal settings. Thus for a given alert condition, multiplealert intensity levels may be stored in the telemetry system 32 memoryalong with multiple expected sensor signal responses or thresholds foreach intensity level. The sensor signal is used in a closed-loopfeedback method to adjust feedback or alert signal control parameters toachieve a feedback or alert signal with the desired intensity at eachlevel.

The feedback or alert signal may be delivered continuously, withcontinuous or stepwise increasing intensity according to a predefinedpattern, until either a maximum alert duration is reached or amonitoring device user or patient acknowledgment is received. In otherembodiments, a feedback or alert signal may be delivered intermittentlyuntil monitoring device user or patient acknowledgement or expiration ofa maximum feedback or alert signal duration, whichever occurs earlier.When delivered intermittently, the feedback or alert signal is deliveredat an initial intensity for a predefined alert interval. The feedback oralert signal is held at the current settings at block 714 until thealert interval has expired as determined at block 719. If the alertinterval expires, the intensity is increased at block 720 and thefeedback or alert signal is resumed for another feedback or alert signalinterval at block 721. A pause between differing feedback and alertsignal intensities may be applied. As a non-limiting example, thefeedback or alert signal may be delivered for a 30 second interval at aninitial intensity. This process may continue until a maximum alertduration is reached as determined at block 716, or monitoring deviceuser or patient acknowledgement is received at block 718.

As non-limiting examples, a maximum alert duration may be set at 5minutes, 10 minutes, 30 minutes, one hour or more and may be setdifferently for different alert conditions, e.g. according to theseriousness of a particular alert condition. Alert intervals appliedduring the maximum alert duration may be set differently for differentalert conditions and different alert intervals may be applied during agiven maximum alert duration. For example, the alert intervals mayincrease in length as feedback or alert signal intensity is increased.

The same is true relative to the amplitude and duration of the alertsignal.

If a maximum alert duration is not reached the alert is terminated atblock 722 and optionally repeated at a later time. As described above, amaximum alert duration may correspond to a continuously deliveredfeedback or alert signal, which may be increased in intensity accordingto a predefined pattern, or an intermittently delivered feedback oralert signal that includes successive intervals of increasing intensityof the feedback or alert signal with intervening pauses of no feedbackor alert signal.

In some embodiments, initial feedback or alert signal settings may be“learned” over time, based on a monitoring device user or patient'sresponse to prior alerting attempts. When a monitoring device user orpatient acknowledgement is received at block 718, the feedback or alertsignal control parameters are stored at block 723. These alert settingsmay be used as the initial feedback or alert signal settings the nexttime the same alert condition is detected (or another condition usingthe same feedback or alert signal). These stored settings can also beused for further analysis. In one embodiment, the user or patient canprovide input relative to the feedback or alert signal. This input canbe used to adjust the thresholds for the alerts. In this way, if aprevious alert was generated and no monitoring device user or patientacknowledgement occurred until a particular sensor signal amplitude orfrequency measurement was reached, the next time the alert is generated,the alert is delivered using a lower setting at which a monitoringdevice user or patient acknowledgement occurred to improveresponsiveness of the monitoring device user or patient to feedback oralert signals.

Adjustment of user or patient parameters at block 712, as the result ofan input provided by the user or patient can be provided for maintaininga feedback or alert signal within a targeted threshold level.

The monitoring device 10 and/or the telemetry system 32 can include afeedback loop. User and patient profiles can be stored in database 18,which can include a non-volatile memory. A user or patient can inputinformation 64 about the desired circumstances or parameters relative toa parameter that is measured by a sensor 14. The processor 20 and/or 34can include a variety of different user and patient profiles relating toinformation obtained from sensors 14. The processor 20 and/or 34 cancustomize by either scaling or modifying the user or patient profilebased on additional user or patient input information.

Furthermore, feedback or alert signals corresponding to different alertconditions may be distinguished by the monitoring device user or patientby delivering the feedback or alert signals to different body locations.When feedback or alert signals are delivered to different bodylocations, multiple sensors may be required in the telemetry system 32system such that a sensor signal responsive to alert stimulation at eachbody location is available. Depending on the number of body locationsand relative distance there between, one or more sensors may beimplanted in order to provide at least one sensor in operative relationto each of the targeted alert stimulation sites.

FIG. 22 is a flow chart, illustrating one embodiment for a method ofestablishing control parameters for a monitoring device user or patientfeedback or alert signal and a sensor signal threshold range for thefeedback or alert signal. At block 802, a set-up procedure is initiated.In one embodiment, this can be achieved using an external programmerhaving a user interface. In another embodiment, information from thetelemetry system database 18 that has been collected is utilized, alongwith any user or patient input. The process shown in flow chart 800 maybe performed at any time. In one embodiment, it is done at the time theuser or patient is connected to monitoring device 10. In anotherembodiment, it is done at a time subsequent the initial connection ofthe user or patient to the monitoring device 10. The process allows theestablishment alert conditions and corresponding feedback or alertsignals tailored to a particular monitoring device user or patient'sneeds. An alert condition is selected at block 804, which may be any ofthe parameters listed above, that receive input from a sensor 14. Alertconditions may be predefined or customized for a monitoring device useror patient.

At block 806, a feedback or alert signal pattern for the alert isselected from a person or from telemetry system database 18, and thelike, which may be a default pattern for a selected alert condition orcustomized using any combination signals from sensors 14. Variousparameters controlling the alert signal may be programmable.

Optionally, at block 808 a test signal is delivered to the monitoringdevice user or patient according to a selected sensor signal value. Inone embodiment, the sensor signal is measured during the test signal atblock 810, which may include measurements of both signal magnitude andfrequency characteristics. At block 812, the patient/user may optionallyprovide input to establish whether the test signal is adequatelyperceivable and distinct from any other feedback or alert signals thathave already been established. User or patient feedback may be receivedby a user interface included in a monitoring device 10, home monitor,device programmer, or other external device in communication with thetelemetry system 32. User or patient feedback may be received by avariety of different ways known in the art when the signal is acceptableor using a signal transmitted by telemetry system 32 or monitoringdevice 10. A feedback or alert signal may be unacceptable to themonitoring device user or patient.

If the signal is not acceptable to the monitoring device user orpatient, or not adequately measured by a sensor 14 to facilitateclosed-loop feedback of the signal, as determined at block 814, one ormore feedback or alert signal control parameters is adjusted at block816, and the process at blocks 808 through 814 repeats until anacceptable feedback or alert signal is established. The feedback oralert signal settings and the sensor signal characteristic(s) associatedwith the acceptable feedback or alert signal are stored at block 818 toestablish a threshold range of the magnitude and/or frequencycharacteristics of the sensor signal for the given feedback or alertsignal.

If additional alert conditions can be detected by the telemetry system32, as determined at block 820, a unique feedback or alert signalpattern can be selected for the next alert condition by returning toblock 804 and repeating the process shown in blocks 804 through 818.Each alert condition may be assigned a unique monitoring device user orpatient feedback or alert signal that is established by storing expectedsensor signal characteristics with corresponding feedback or alertsignal parameters. The monitoring device user or patient can providefeedback such that each feedback or alert signal is easily perceived,recognized and distinguished from other feedback or alert signals.

For each acceptable feedback or alert signal, a sensor threshold levelis established, which may include both a magnitude component and afrequency component. The stored sensor signal thresholds allow thefeedback or alert signal to be adjusted as needed during an actualmonitoring device user or patient alert to most closely match themagnitude and/or frequency characteristics of the established feedbackor alert signal. The monitoring device user or patient can be “trained”to recognize different feedback or alert signal patterns, intensities(strength or duration of the muscle response), and/or locations andtheir correspondence to different alert conditions.

Once all sensor-based threshold characteristics have been stored for allalert conditions, the process is terminated at block 822. The storedsensor signal data can then be used in a closed-loop feedback method forcontrolling feedback or alert signal stimulation parameters duringnormal operation of the telemetry system 32 as described in conjunctionwith FIG. 21.

As illustrated in FIG. 21, one or more analysis tools 724 at thetelemetry system 32 the user information and produces analysisinformation that is sent to the telemetry system 32. The one or moreanalysis tools 724 can be part of or separate from the database 18.

The database includes base standards for at least one of user,activities, behaviors, habit information and health information that isindicative of a healthy lifestyle of activities, behaviors, habitinformation, exercise programs and health condition. The userinformation received from the monitoring device 10 is analyzed relativeto the base standards in the database. In one embodiment, the basestandards in operation are updatable. The update information includesupdated base standards.

The foregoing description of various embodiments of the claimed subjectmatter has been provided for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit the claimedsubject matter to the precise forms disclosed. Many modifications andvariations will be apparent to the practitioner skilled in the art.Particularly, while the concept “component” is used in the embodimentsof the systems and methods described above, it will be evident that suchconcept can be interchangeably used with equivalent concepts such as,class, method, type, interface, module, object model, and other suitableconcepts. Embodiments were chosen and described in order to bestdescribe the principles of the invention and its practical application,thereby enabling others skilled in the relevant art to understand theclaimed subject matter, the various embodiments and with variousmodifications that are suited to the particular use contemplated.

What is claimed is:
 1. A method for using telemetry data related tosleep of an individual, comprising: providing a monitoring device with amicrophone, an RF transmitter and sensors to determine air quality,sound level/quality, light quality and ambient temperature near theindividual; detecting the individual's movement sounds using anaccelerometer; using the accelerometer and the monitoring device toassist in determining individual sleep information and sleep behaviorinformation; using the microphone to record individual movement soundsdetected by the accelerometer; and using the accelerometer to cause themicrophone to stop recording the individual's movement sounds when themovement sounds are not directed to a sleep related parameter; receivingthe individual's movement and monitoring device information at atelemetry system that includes a database; analyzing the individual'smovement information and the monitoring device information to assistwith one or more analysis tools at the telemetry system to calculate orderive sleep onset and wake time, sleep interruptions, and the qualityand depth of sleep; and producing analysis information for theindividual's sleep onset and wake time, sleep interruptions, and thequality and depth of sleep that is displayed on the monitoring device.2. The method of claim 1, further comprising: providing feedback to theindividual in response to producing the analysis information.
 3. Themethod of claim 1, further comprising: providing an alert to theindividual in response to producing the analysis information.
 4. Themethod of claim 1, further comprising: providing a list of actions forthe individual to take in response to the producing the analysisinformation.
 5. The method of claim 4, further comprising: accessingfrom the database base standards selected from a individual's movementsounds.
 6. The method of claim 5, further comprising: updating the basestandards.
 7. The method of claim 1, further comprising: communicatingone or more feedback signals or alerts to the individual.
 8. The methodof claim 1, further comprising: providing control data.
 9. The method ofclaim 1, further comprising: communicating feedback at the telemetrydevice to the individual using an audio device of display.
 10. Themethod of claim 1, further comprising: comparing the individual movementsounds to a threshold level.
 11. The method of claim 10, furthercomprising: predefining or tailoring the threshold level.
 12. The methodof claim 1, further comprising: providing feedback to the individual inresponse to detecting amplitude or frequency of the accelerometer.